WO1992007519A1 - Surgical closure - Google Patents

Abstract

A surgical closure which can be repeatedly opened and closed, especially one for an abdominal incision, consisting of flexible fabric or plate-like securing means which can be firmly secured to the bodily tissue close to the incision but can be released therefrom and with a closure bringing together its end regions above the incision, which can be opened and closed at any time, is to be improved in such a way that a completely pressure-tight closure is obtained but which may be opened as often as desired. This is achieved in that it is fitted with a securing component (15) surrounding the incision on all sides which has an aperture (4) applicable above the incision and consists of a tube (5) of flexible material extending upwards from and surrounding the aperture (4) and the tube (5) itself acts as the closure or is fitted with such.

Description

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The present invention relates to a wound closure according to the preamble of claim 1.

Such a wound closure / 3 is known for example from DE-PS 34 44 782. This undverschlu / 3 serves in particular as a temporary abdominal cavity closure / 9, preferably in the postoperative treatment of peritonitis.

Peritonitis as a secondary form, which develops as a result of perforation of a hollow organ or as a postoperative complication, is still highly lethal today. With increasing incidence, it represents a central surgical problem.

The abdominal cavity is subject to a physiological, directed fluid flow, which occurs primarily through small openings in the underside of the peritoneal diaphragm. In this way, the bacteria are supplied to the systemic defense via the lymph channels. The absorption capacity of the intra-peritoneal fluid is increased by the mobility of the diaphragm and the intraperitoneal pressure. In the context of peritonitis, this outflow is blocked by the pathophysiological formation of fibrin and bacteria and the circulation is hampered by fibrin-related adhesions. The defense system is disturbed and there is an increase in the bacterial masses, their toxins and fibrin. If it is not possible to stop the progression of peritonitis in good time, a pathophysiological cascade gets underway, which is constantly increasing in dynamics and can no longer be stopped at a certain point. In order to clean the abdominal cavity, rinsing is carried out intraoperatively with physiological saline solution until the rinsing liquid remains clear. Bacterial masses, fibrin, devitalized tissue, toxins and also blood residues (also hemoglobin promotes the attack of an infection) are to be removed as completely as possible with this mechanical cleaning in order to create an optimal prerequisite for the healing together with the surgical focal remediation.

It is crucial in the postoperative phase, in which the patient's fate usually decides to recognize a worsening of the situation as early as possible and, if necessary, to remedy the cause immediately (eg correction of a suture insufficiency after a perforated gastric ulcer has been overstitched) and through effective lavage, if possible from

1st postoperative day to ensure clear conditions (newly formed blood, fibrin and bacteria should be flushed out).

In postoperative lavage, the strategy of the open abdomen for the interval rinsing and the rinsing treatment for the closed abdomen are known.

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This so-called open abdomen is made possible by the slide slide closure and the zipper as a more passable abdominal cavity closure with the advantages that repeated intra-abdominal accessibility is guaranteed and the surgeon is convinced of the success of the herd restoration with every flush and thus the course of the treatment Can control peritonitis. Postoperative intra-abdominal growths can be loosened and fibrin deposits removed. The typical drainage complications are eliminated. (Sealing of the drainage against the abdominal wall, blockage or laying of the drainage, source of infection). A relaparotomy ^" is no longer necessary. The disadvantage here is that it is not possible to rinse directly after the operation and that continuous rinsing is not possible. Interval rinsing is particularly frequent and stressful for the patient when the patient's condition is critical. The interval rinsing must be carefully prepared; it is carried out in the operating room (the abdomen is open during rinsing) and with general anesthesia. The advantages of the principle of peritoneal dialysis must be dispensed with, since the previous abdominal cavity closures did not seal the abdomen tightly. The rinsing effect remains limited, since a desired intra-abdominal pressure does not remain, and the rinsing liquid preferably only flows in preformed rinsing lines. In addition, a part of the rinsing fluid seeps into the bed after the temporary closure of the abdominal wall, which, in addition to an additional source of infection, ineffective rinsing and additional stress on the patient, means a considerable additional outlay for the nursing staff. Patients with an open abdomen are currently among the most care-intensive patients. If a so-called zipper or slide slide closure is sewn in as a temporary abdominal cavity closure, there is another disadvantage. Once cut and sewn in, it is no longer possible to adapt to the tension in the abdominal wall. Due to the dull, atrophied swelling of internal organs in the course of peritonitis, the tension of the abdominal wall can increase considerably with the risk that the sutures tear. On the other hand, later in the recovery phase, in which the internal organs swell, the edges of the wound must be gradually brought together again to form the definitive abdominal wall suture. The typical zipper complications can also be expected (pinching, hooking). There is no special edge structure for sewing into the fascia, so that only the individual seams wear. These are often not tight and tear out easily. Continuous peritoneal lavage with a closed abdomen offers the advantages that effective rinsing treatment can be started immediately after the operation, and the task of conventional Redon suction drainage can thus be replaced much more effectively. This has a weak suction power, sucks only where it is located. In addition, it clogs easily and then leads to the assumption that the wound space is already empty. Due to the dense system, an intraperitoneal pressure can be built up and dosed. The rinsing liquid (possibly with the addition of antibiotics) thus also reaches the critical "weather corners" of the abdomen. It is not just rinsing lines that are created as in the case of leakage without pressure. Less fibrin-related adhesions form, since the abdomen contents "float" and fibrin (among other things) is effectively rinsed out (thus simultaneously ileus prophylaxis).

Peritoneal dialysis is possible. An increase in the retention values (creatinine, urea, potassium) in the event of impending renal insufficiency can thus be absorbed simply by using a commercially available dialysis fluid as the rinsing fluid. The patient can be dialyzed without further ado without having to be included in the complex hemodialysis program. The associated disadvantages, such as can arise from the manipulation of the blood volume, also disappear. The flushing can be carried out by a machine according to a desired scheme, which significantly eases the burden on the nursing staff. A simple check of the success of peritonitis is possible by chamber counting the leukocytes in the rinsing liquid. A run-out assessment can be carried out very simply by inspection (turbidity, fibrin or blood admixtures). Rinsing water samples for resistance determination of the bacteria can be taken at any time via the catheter, and other substances can also be applied. (ZB electrolytes, protein, heparin). The disadvantage here is that the abdomen is no longer accessible and therefore there is no longer any direct visual control, which is important if the discharge changes pathologically or the clinical condition of the patient deteriorates. Sealing and source of infection of the drainage passage sites, as well as blockage or relocation of the drainage are typical complications. If access to the abdomen is required again, a relaparotomy must be carried out.

Despite the promising approaches, the strategy of the closed abdomen has not been able to prevail in practice because the disadvantages are in the foreground.

The object of the present invention is to improve a temporary intracorporeal wound closure of the type mentioned at the outset in such a way that a completely pressure-tight closure is obtained, but which can nevertheless be opened as often as desired at any time. In addition, there should be the possibility of repeatable, stepless tension regulation of the abdominal wall and thus also of the intraperitoneal pressure, without the critical connection between the edge of the fixing element and the corresponding body tissue layer having to be separated.

This object is achieved by the features specified in the characterizing part of claim 1.

With the present invention, the advantages of the two strategies described above can be combined, so that new, expanded therapeutic options are available, for example in abdominal surgery, the use of which is not limited to the treatment of peritonitis, but also, for example, in the treatment of peritonitis Treatment of pancreatitis appears promising. A temporary occlusion of the abdominal cavity is in principle possible if postoperative complications are to be expected. It can also be used as a temporary closure of other body cavities. Thanks to integrated connections for drainage hoses at the same time, the advantages of a continuous closed irrigation system or peritoneal dialysis can be exploited. A further improvement can be achieved by a special structure and by the shape of the edge structure, which enables a non-positive and tight connection between the base plate and the fascia. In addition, a fibrin glue can be used.

Preferred embodiments of the invention result from the subclaims.

Further advantageous details of the invention are explained in more detail below with reference to the exemplary embodiments illustrated in the drawing. Show it:

Figure 1 is a view of an inventive

Wound closure, FIG. 2 shows a top view of the wound closure according to FIG. 1 in the open state, FIG. 3 shows a cross section through the wound closure according to FIG. 1, according to section line I-I in FIG. 2, FIG. 3a shows an enlarged detail of the

Detail E of Figure 3, Figure 3b and other connection options of the

3c fixing element with the fascia in the form of a clamp closure, FIG. 4 shows a top view of the wound closure according to FIG. 1 in the closed state, FIG. 5 shows a cross section through the wound closure according to FIG. 1, according to section line II-II in FIG. 4 and FIG. 5a an enlarged section of Figure 5, relating to the rod 26th The wound closure according to the invention can be sewn into the fascia 1, that is the tendon plate of the abdominal wall, on the underside of the abdominal wall 2, for example as a temporary abdominal cavity closure.

For this purpose, after selecting the appropriate size from a plurality of wound closure types in relation to the length of the abdominal incision, the edge 3 of a single fixing element 15, which surrounds the wound on all sides, is always referred to below as base area 15a, with its one to be provided above the wound

Opening 4 is pushed under fascia 1 on all sides and sewn to fascia 1 according to a possible embodiment according to FIGS. 3 and 3a. The opening 4 selected in accordance with the cut length can adapt to the wound gaping depending on the tension of the abdominal wall. This is achieved especially when the opening 4 is designed as a cutout which extends far into the corners in the form of a lancet or approximately an ellipse or a wide gap with rounded end faces. A prerequisite for this possible adaptation of the opening 4 is that the base 15a consists of flexible material which can also be elastically stretchable. However, the elasticity should not be too great in order to be able to generate sufficient transverse tension in the direction of the contraction of the wound.

The opening 4 is surrounded by a tube or funnel-shaped tube 5, for example, which is arranged so as to protrude perpendicularly to the base surface 15a and is made of flexible material with possibly low elasticity. The term tube is to be understood as a tubular structure of any cross-sectional shape, which extends from the opening 4, ie away from the wound, and forms a liquid-tight sleeve over its entire length. On one side of the tube 5, outside of the same, a cover flap 6 is provided on the base 15a or on the tube 5, which flaps over after the folding, for example after folding and / or after the tube 5 has been rolled over the tube folding or the tube roller 19 is and on the other side of the tube 5 with the base 15a can be attached so that the rollover length is variable.

However, an embodiment is also conceivable in which the material for the base surface 15a, for the tube 5 and also for the cover flap 6 is selected with regard to the elasticity so that a sudden increase in intra-abdominal pressure, such as a coughing thrust, at least partially can be intercepted. In this way, the forces occurring on the connection between the base surface 15a and fascia 1 can in any case be reduced.

In order to enable a surface-engaging, force-fit and tissue-compatible connection between the base surface 15a and the fascia, the edge 3 of the fixing element must sufficiently underlap or engage under the fascia 1 on all sides, consist of biocompatible or tissue-compatible material and have a suitable structure . Particularly suitable as a biocompatible material is a textile material known under the trade name "Gore-tex", as is already used in vascular surgery. Such blood vessel prostheses can be sewn in tightly and withstand systolic blood pressure peaks up to more than 200 mmHg.

Within the scope of the present invention, there are several possibilities in the formation of the edge 3. A simple design does not meet the requirements for a stable and tight connection between the base surface 15a and the fascia 1, not even with the support of an adhesive, preferably a fibrin adhesive. the edge 3 can then be formed, as shown in FIG. 3a. A sufficiently rigid lower layer 7 distributes the pressure, which is generated by the seam or by several seams 10, over a large area against the fascia l and at the same time offers a supporting layer for the fine tips or teeth 9, which are flat in the fascia 1 to grab. The tips or teeth 9 break through a soft sealing layer 8, which is located above the lower layer 7. In the simplest case, the seam 10 only holds the fascia 1, but can also all according to seam techniques, such as with a belly

Detect layers of the abdominal wall 2 and are supported on the skin 12 via a pressure-distributing disk 13 (FIG. 1). Furthermore, it is conceivable that a sewing or stapling device is used to create a tight seam on the fascia 1. The connection can also be supported and sealed with a fibrin adhesive. In this context, the use of silicone as an additional sealing material is also conceivable.

It is particularly advantageous in the production of the seam 10 between the fascia 1 and the base 15a that one has unhindered access to the surgical wound through the central opening 4, since the opened tube 5 collapses flat due to its flexibility or is folded flat can. The needle guide on the intraperitoneal side can be visibly checked. Optionally, abdominal cavity content (s), for example intestinal sections, can be pressed out of the way of the intraperitoneal needle guide. In addition to the edge 3, a plurality of drainage connections 14 are preferably on one side of the fixing element 15

Base area 15a integrated or retrofittable there with a screw thread, both for or after externally leading upper connecting piece 16, as well as for the lower connecting piece 17 leading inwards. If no drains are in use, the upper connecting pieces 16 are closed with screw plugs. In a preferred embodiment, the drainage passages are incorporated in two reinforcement plates 18, which enclose the base area 15a flat and pressure-tight from above and below. If one or more drainages are needed, they can be placed in the abdominal cavity with the tube 5 open and screwed onto the lower connector 17. The extracorporeal drainage 28 can be screwed onto the upper connection piece 16 as a continuation even when the tube 5 is closed. Since the problems of leak tightness and a source of infection at a leaky drainage passage point, such as those that occur in the case of a separate catheter passage through the abdominal wall, are eliminated, it is easier to decide on the use of several drainages via the integrated drainage connections 14 and the system in principle also for lay out larger-lumen drainages. Due to the simple intra-abdominal accessibility, it is possible here to remedy the intra-abdominal cause through the opening 4 even if the intra-corporal drainages 29 lose their function.

Starting at the inner edge of the base area 15a, the tube 5, which is open at the top, rises. It is firmly and pressure-tightly connected to the base area 15a and can close the central opening 4 and thus the abdominal cavity in a pressure-tight manner.

According to a preferred exemplary embodiment, the tube 5 is closed by a rolling-in process via a rod 26, for example divided into two. FIG. 5a shows that one rod half 21 is equipped with pointed pins 31 which pierce the two walls 22, 23 of the tube 5 which have been folded together at the top, the folded tube walls 22, 23 being able to be folded beforehand. The second rod half 24 is pressed onto the pins 31 of the first rod half 21 via corresponding receptacles or holes 25. Fixed in this way, the merged tube 5 can be rolled over the rod 26 designed as a round rod and formed into a tube roller 19. Depending on how far it is rolled and how the longitudinal section profile of the rod 26 is designed, different partial tensions can be generated on the wound edges. The rolled tube 19 is now finally fixed with a cover flap 6. This cover flap 6 is firmly connected to the base surface 15a on the drainage connection 14 side. It reaches over the rolled-up tube 19 and stops on the opposite side. An adhesive fastener, such as a Velcro fastener 30, is preferably used for this purpose.

In another embodiment, the rod 26 can be used exclusively as a rolling aid and can be pulled out after the rolling-in process. The ends of the tube roller 19 can also be folded inwards and thus fixed by the overlapping cover flap 6. In special cases, a kind of abdominal belt can be useful as an additional safeguard.

According to a further embodiment, as shown in FIG. 3b, the tight closure between the fascia 1 and the base 33a of the fixing element 33 can be designed as a clamp closure 32 as follows.

In order to enable a large-area, non-positive, possibly combined non-positive and positive, and tight connection between the base 33a of the fixing element 33 and the fascia 1, the inner edge 34 of the fixing element 33 must make the fascia 1 sufficiently wide on all sides grip or underlap, so that from above onto the inner edge 34 pressed clamping pieces 35 can clamp the fascia 1 sufficiently durable and tight.

As FIG. 3b shows, the inner edge 34 of the clamp fastener 32 preferably has a width of approximately 2 cm and is equipped with barbs 36, which are preferably one to two cm long. Pressed against a clamping piece 35 attached from above, these barbs 36 pierce the fascia 1 from below and possibly also a part of the muscle layer adjoining upwards. In the clamping pieces 35, which are preferably constructed as a lattice block 40, the barbs 36 can snap into the individual openings of the lattice block 40, depending on the pressure to different extents, in the corresponding horizontal layers or lattice planes 41 of the lattice block 40. Additional inner and outer Seals 37, 38 seal the clamp closure 32 in a liquid-tight manner. It is easily possible to press the two complementary clamping parts 35, 36 together simultaneously with the thumb and the index finger of one hand, since through the central opening 4 the index finger around the folded tube 5 under the

Base 33a can grip. The individual clamping pieces 35 are cut appropriately in shape and length with a suitable cutting tool and seal the wound edge all around.

When using lattice blocks 40 as clamping pieces 35, these consist of one or more lattice planes 41, which are provided with openings 42 for producing a fixed latching connection, which correspond to the prongs 39 of the barbs 36.

In order to ensure a secure seal of the clamping closure according to FIG. 3b, sealing elements 37, 38 which completely encompass the wound opening 4 are provided in the lower edge region 34 of the fixing element 33 between the latter and the fascia 1 on the one hand and between the fascia 1 and the clamping pieces 35 on the other hand. It is important that when using a plurality of lattice blocks 40 along the wound opening 4, these are spaced apart from one another to such an extent that they can be laterally displaced relative to one another along the wound opening 4.

According to another embodiment variant, the clamping pieces 35 can consist of elastically flexible solid material, for example of a rubber-elastic material or of rubber-elastic plastics, into which the barbs 36 can be pressed in order to produce a sufficiently force-locking connection.

The release of the grating blocks 40 or generally the clamping pieces 35 from the inner edge of the base 33a of the fixing element 33 is expediently carried out using known lever tools.

According to the exemplary embodiment according to FIG. 3c, the inner edge 34 of the base 33a of the fixing element 33 has a recess 43 which completely surrounds the wound opening 4 and which tapers in cross section on the surface in the direction of the fascia 1, so that one or more clamping pieces 35 fit into it Recess 43 with the fascia 1 interposed, optionally in conjunction with other body tissue structures, can be locked as a sealing element. The clamping pieces 35 preferably have a circular cross section, so that they can be snapped into the likewise at least approximately circular recess 43 and are fixed in a non-positive and positive manner in this position due to the elastic design of the fixing element 33. This atraumatic clamp closure is characterized in that a preferably slightly flexible, cuttable rod, preferably a round rod, can be pressed into the recess 43 mentioned, and that this clamp connection ensures that the fascia 1 in between is not damaged. In addition to the previous explanations, it may also be expedient to make markings, for example in the form of numbers, letters, symbols or the like, on the base 15a or 33a of the fixing element 15 or 33.

It is also expedient if the entire wound closure, or at least those parts thereof, which come or can come into direct contact with the body tissue, consist of a bio-compatible material, such as the one mentioned earlier under the trade name "Gore-" tex "well-known textile.

Even if, as can be seen in particular from FIGS. 3 and 5, the tube 5 and the fixing element 15 are preferably formed in one piece, it is within the scope of a possible modification of the invention to design the tube 5 and the fixing element 15 as separate components and then connect them tightly together.

According to a preferred embodiment, the fixing element 15 consists of a single component. However, this does not rule out producing the fixing element 15 from a plurality of fixing element parts and connecting them tightly to one another.

Suitable materials for the tube 5 are, in particular, flexible plastic films or textile plastics which can be provided on the surface with plastics or with other sealing and / or tissue-compatible materials.

Further advantages of the wound closure according to the invention can be seen in the use of laparoscopy. For this purpose, adapter pieces, for example, can be attached to the drainage connections 14, through which laparoscopic examinations and / or interventions can be carried out. Finally, it is also advantageous that the wound closure according to the invention opens up the possibility of different irrigation or irrigation / suction schemes. Postoperative continuous open dorsoventral abdominal irrigation can also be easily achieved with the temporary abdominal wall closure according to the invention. The cumbersome, disadvantageous palisade stabilization of the wound opening is eliminated. The drainage connections 14 can be used as a flushing inlet and a large-lumen drainage placed in the central tube opening 4 and sealed with the tube 5, for example with a hose clamp or a quick connector, as a suction pipe. In addition, a probe for measuring and ongoing control of the intraperitoneal pressure can be connected via a drainage connection 14 as permanent access.

Finally, the clamp closure according to the invention enables faster implantation than the time-consuming sewing.

Claims

Claims 1. Wound closure which can be opened and closed repeatedly, in particular abdominal wall wound closure, consisting of flexible cloth-like or plate-shaped fixation elements which are connected to the body tissue adjacent to the wound, but can be releasably connected, and a closure which closes the free end regions thereof above the wound , which can be opened and closed at any time, characterized in that it consists of a fixing element (15) which surrounds the wound on all sides and has an opening (4) to be made above the wound, and from a surrounding the opening (4) the opening (4) upwardly extending tube (5) consists of flexible material and the tube (5) itself serves as a closure or is provided with such. 2. Wound closure according to claim 1, characterized in that the opening (4) is lanceolate or elliptical. 3. Wound closure according to claim 1 or 2, characterized in that the tube (5) on the fixing element (15) is arranged pressure-tight. 4. Wound closure according to one of claims 1 to 3, characterized in that the fixing element (15) in the area surrounding the tube (5) has at least one drainage hose connection (14) or the fixing element (15) with at least one such connection can be equipped. 5. Wound closure according to one of claims 1 to 4, characterized in that on one side outside the tube (5) a cover flap (6) is attached, which can cover the folded tube (5) and on its fastening side opposite side is releasably attachable so that its overlap length is adjustable. 6. Wound closure according to claim 5, characterized in that an adhesive closure (30) is provided for fastening the free end of the cover flap (6). 7. Wound closure according to one of claims 1 to 6, characterized in that the tube (5) is foldable. 8. Wound closure according to one of claims 1 to 6, characterized in that the tube (5) can be rolled up. 9. Wound closure according to one of claims 1 to 8, characterized in that the tube (5) starting at the free edge, can be rolled up via a rod (26). 10. Wound closure according to claim 9, characterized in that the tube (5) in the region of its free edge has fixing means for attaching and / or stapling the rod (26). 11. Wound closure according to claim 9 or 10, characterized gekenn¬ characterized in that the rod (26) along its longitudinal axis has different diameters. 12. Wound closure according to one of claims 9 to 11, characterized by the fact that when the tube (5) is rolled up, a fixing device (30) for holding the tube roller (19) is provided in the region of the tube roller (19) formed. 13. Wound closure according to claim 12, characterized in that an adhesive closure (30) is provided for fixing. 14. Wound closure according to one of claims 1 to 13, characterized in that it consists of biocompatible material, at least in the area that comes into direct contact with body tissue. 15. Wound closure according to one of claims 1 to 14, characterized in that the fixing element (15) has one or more markings. 16. Wound closure according to one of claims 4 to 15, da¬ characterized in that drainage hose connections (14) are provided with different diameters or can be attached. 17. Wound closure according to one of claims 4 to 15, characterized in that the drainage hose connections (14) are arranged secured against twisting. 18. Wound closure according to one of claims 1 to 17, da¬ characterized in that it is pressure-tight, pressure-tight attachable to the body tissue and pressure-tight sealable. 19. Wound closure according to one of claims 1 to 18, characterized by the fact that a longitudinally divided rod (26) is provided for rolling up, one rod half (21) of which has inwardly projecting pins (31) which are in bores (25 ) the other half of the rod (24) can be inserted or clamped and which can penetrate the partition walls (22, 23) of the tube (5). 20. Wound closure according to claim 1, characterized in that the connection of the fascia (1) is made via a clamp closure (32) (Figures 3b and 3c). 21. Wound closure according to claim 20, characterized in that the fascia (1) engaging under the edge region (34) of the base (33a) of the fixing element (33) with the fascia (1) aligned barbs (36) which with the Fascia (1) clamps (35) that can be applied from above can be connected in a non-positive and / or positive manner. 22. Wound closure according to claim 20 or 21, characterized gekenn¬ characterized in that the clamping pieces (35) are designed as a lattice block (40). 23. Wound closure according to claim 22, characterized in that the lattice blocks (40) consist of one or more lattice planes (41) which have openings (42) corresponding to the barbs (39) of the barbs for a snap connection. 24. Wound closure according to one of claims 20 to 23, characterized in that in the lower edge region (34) of the fixing element (33) between this and the fascia (1) on the one hand and between the fascia (1) and the clamping pieces (35) on the other hand, sealing elements (37, 38) that completely surround the wound opening (4) are provided. 25. Wound closure according to one of claims 21 to 24, da¬ characterized in that the clamping pieces (35) are spaced from each other so that they are laterally displaceable against each other along the wound opening (4). 26. Wound closure according to claim 21, characterized in that the clamping pieces (35) consist of resilient Vollmate¬ rial, into which the barbs (36) can be pressed. 27. Wound closure according to claim 20, characterized in that the inner edge (34) of the base (33a) of the Fixierele¬ elementes (33) has a wound opening (4) completely surrounding recess (43) which superficially in the direction of fascia ( 1) tapers in cross-section, so that one or more clamping pieces (35) can be locked in this recess (43) with the interposition of the fascia (1), possibly in conjunction with other body tissue layers, as a sealing and / or holding element (Figure 3c).